Grounds of Patent Opposition

A patent is an exclusive privilege given to the original author for a novel product or for a novel method offering a specific means of doing something, or for a new technological approach to a problem to be revealed. It gives the inventor the right to develop, sell his invention or product with a monopoly. It is also very critical that only those inventions that justify the exclusive right and comply with the requirements of patentability are granted a patent. Thus, patent opposition proceedings are intended to avoid the unlawful acquisition of patents and the allegations of frivolous or minor inventions.

In this article, Vatsala Sood analyses the laws required to obstruct the unlawful grant of a patent and the regulations provided for the pre-grant and post-grant of a patent under the Indian Patent Act.

I. Introduction

A patent guarantees a right to the exclusion or a monopoly on a product or process. This is granted because the proprietary right is justified by others who satisfies the requirements for patentability. Under the Indian Patents Act, the opposition mechanism in India exists to restrict individuals from receiving patents wrongfully and to prevent unnecessary or petty inventions. The patent rights issued under the Indian Patents Act are not meant to use the invention but to prohibit anyone from using the technology by anyone other than the legitimate owner of the innovation.

There are two clauses under the Indian Patent Act where, depending on the level of the patent, the opposition may be filed either by means of a pre-grant opposition or a post-grant opposition clause. The recent increase in patent filings in India can be credited to the transformation in the Indian patent system on 1 January 2005, when the Trade-Related Aspects Intellectual Property Rights Agreement (TRIPS) was signed by India, in which Section 25 of the Act was amended to incorporate an “integrated” approach of pre-grant and post-grant opposition in India.

A clause concerned with the opposition framework is in the patent laws of different countries. The system of opposition is an administrative mechanism available under the patent or trademark act of the respective country, which facilitates the procedure by which particular individuals can contest a patent application. The opposition structure of the Indian Patents Act discussed in section 25 is nothing but a method to hinder the way patents are issued when they are minor or frivolous. Sec 25 was amended by the Patents Reform Act 2005 with respect to the trade-related aspects of intellectual property rights. An integrated pre and post opposition mechanism was implemented in the amendment. Previously, there was no procedure for post-grant resistance and termination was the only relief[1].

If correctly used, patent opposition may serve as an effective method to discourage the awarding of unfounded patents. Although this aim can be accomplished by revocation and other litigious options, opposition works as a more cost-effective course. Nevertheless, it calls to mind the abuse of opposition to prohibit even certain patents that have high economic merit from being issued and to purposely influence rivals’ enterprises. Nevertheless, to mitigate those concerns, the opposition mechanism has its own checks and balances[2].

When an issued patent fails the opposition test, a much higher valuation of the patent is obtained. India’s patent opposition mechanism is special because, at two different points of patent prosecution, it offers two kinds of patent opposition process:

• a pre-grant opposition; and
• a post-grant opposition.

II. Pre-grant opposition proceedings – grounds and procedure

Under Section 25(1) of the Patents Act 1970, any person can on the basis of the grounds set out in Sections 25(1)(a) to (k), object in writing to the grant of a patent after the publication of the patent application, but before the grant of the patent. The opposition representation is provided in Form-7(A) along with an argument and proof in favour of the opposition. When required, the adversary can even seek a hearing.

A timeframe of six months prior to the award of a patent from the date of publication of the application was deliberately maintained by the legislature, allowing third parties an ability to challenge the grant of a patent. However, only if an application for review of a patent application has already been filed can a representation be filed.

After the representation has been considered, if the controller determines that there is validity in the representation, he or she shall advise the claimant of the opposition. Following receipt of the notice, the claimant shall, within three months of receipt of the notice, file a reply to the representation along with proof, if any is appropriate.

After evaluating the representation of the opponent and the reply of the applicant, along with proof from both parties and hearing both parties, the controller may if desired, either deny the pre-grant representation and grant a patent or ask the applicant, before continuing to grant, to amend the full specification to his or her satisfaction.

Grounds for pre-grant opposition[3]

A pre-grant opposition can be filed only on the following grounds:

• wrongful obtainment of the invention (Section 25(1)(a) of the Patents Act);
• anticipation by prior publication (anywhere in the world) (Section 25(1)(b));
• anticipation by prior claiming in India (Section 25(1)(c));
• public knowledge or public use in India before the priority date (Section 25(1)(d));
• obviousness and lack of inventive step in the invention (Section 25(1)(e));
• being an excluded subject matter (such as those inter alia provided in Section 3) (Section 25(1)(f));
• insufficiency of disclosure of the complete specification (Section 25(1)(g));
• non-compliance of the requirement of Section 8 or furnishing materially false information (Section 25(1)(h));
• non-filing of the application within 12 months of filing the first application in a convention country (Section 25(1)(i));
• non-disclosure or wrongful mention of the source or geographical origin of biological material (Section 25(1)(j)); and
• anticipation with regard to traditional knowledge of any community anywhere in the world (Section 25(1)(k)).

III. Post-grant opposition proceedings – grounds and procedure

Pursuant to Section 25(2) of the Patents Act, any interested party can by providing notice of opposition to the controller, file a post-grant opposition within 12 months of the date of publication of the grant of a patent on any of the grounds specified.

There are similar grounds for post-grant opposition to those for pre-grant opposition. Following receipt of the notice, the controller shall advise the patentee of the challenge and shall direct the opposition board to investigate the opposition and to make its recommendations to the controller.

IV. Opposition Board

The opposition board consists of three members, each of whom is elected to preside over the board by the controller. In addition, except for the examiner who has dealt with the patent application, the members of the board are patent examiners.

V. Filing documents

The opponent is expected to file a written declaration of opposition and proof in a duplicate copy. In a written declaration, the adversary must specify:

• The nature of its interest;
• The evidence that the case is based on;
• The relief that was sought; and
• Any evidence.

Within two months after receipt of the notice of objection, the patentee shall send a written declaration along with proof, if any to the patent office, along with a copy to the opponent, if it wishes to appeal it. If this is not challenged by the patentee within two months, the patent is considered to have been cancelled.

After that, the opponent could file its reply proof with the patent office within one month of receipt of the patentee’s reply statement.

Additional proof, if any, can be filed only with the approval of the controller.

The opposition board shall review the patent on the basis of the documents sent by the opponent and the reply given by the patentee and shall, within three months of the date of the documents forwarded to the opponent, make a recommendation to the controller with the explanations for each of the grounds referred to in the notice of opposition

VI. Hearing

Upon receipt of a recommendation from the opposition council, the controller shall set a date and time for all parties to be heard. At the time of the hearing, the members of the opposition board are present.

The controller shall, after hearing both parties or without a hearing if no party wants to be heard and taking into account the recommendation of the opposition board, order that the patent be either retained, amended or withdrawn.

VII. Significance of the Opposition Board

In Cipla Ltd. v. Union of India & Ors, the Supreme Court duly stressed the importance of the advice of the Opposition Council. In that case, the Supreme Court ruled that the Opposition Board’s proposals had to be made available to the parties so that at the time of the hearing, they could effectively advance their respective cases before the Controller.

The Court held that although the Act and the Rules do not give the Opposition Board or the Controller any obligation to provide either party with a copy of the report, since the report is crucial to the decision-making process, it is necessary to read the principles of natural justice into those provisions. Therefore, before the Controller passes the order, a copy of the report/recommendation of the Opposition Board should be made available to the parties.[4].

VIII. Procedural Distinctions Between Pre Grant And Post Grant Patent Opposition in India

Both the pre-and post-grant opposition contain almost identical grounds for proceeding with the opposition, and nothing excludes a pre-grant opponent from consequently filing a post-grant opposition. However, despite the resemblances, there are also several procedural differences that are illustrated below between the two types of opposition:

The most important difference between a pre-grant and a post-grant opposition is that “any person” may initiate pre-grant proceedings, whereas a post-grant opposition may be introduced only by a “person interested.”

In infringement litigation, the next notable distinction is that during pre-grant opposition proceedings, infringement proceedings cannot be initiated as the patent is still at the stage of the application, whereas infringement proceedings may be initiated in the context of post-grant opposition proceedings.

Section 25(1) of the Act does not openly provide an opportunity for the patent claimant to be heard in the case of pre-grant opposition.

In comparison, the Indian Patents Act does not expressly authorise a pre-grant challenge to be heard by the opponent. The respondent needs to make a case for a trial and the laws do not clarify how to hold a hearing. The right of the opponent to be heard rests entirely on the judgement of the controller, who judges the same on the basis of the objection. Furthermore, it is therefore not clear from the rules whether the competitor can be heard in the applicant’s presence. By comparison, in a post-grant opposition, the opponent can, irrespective of the validity of the notice of opposition, continue with the event.

Moreover, according to the stance taken on various occasions by IPAB; in a pre-grant opposition, there is no recourse against an order of the controller except to file a written petition under the Indian constitution.

The key downside to the post-grant challenge process is that this recourse is possible only in the courts, making a long process of redress and enabling the patent holder to enjoy an unfair privilege in the case of poor patents. In India given the protracted nature of the judicial process, this is of particular concern.

On the other hand, pre-grant resistance is more cost-effective and helps in a quicker disposition of merit claims, thus reducing the expenses accrued in contesting the post-grant proceedings.

Compared to post-grant opposition, this mechanism is faster when trials and prolongation of hearings take place in a conventional way that occurs in the courts. There is no fee set for filing a pre-grant opposition, unlike post-grant opposition[5].

IX. When is a Patent Deemed to be Granted?

The date of grant of the patent plays a very significant role in both pre-grant and post-grant opposition, as it specifies the time during which any opposition can be lodged. However several questions have arisen as to what is assumed to be the date of the issuance of a patent, as there is a lapse between the grant order and its eventual publication.

In Sugen Inc v. Cipla Ltd, the court decided whether it was possible to award a patent under the Patents Act. The court held that in the event of pre-grant opposition, the date of the grant was the date on which the grant order was given by the controller and not the day of its publication in the Journal of the Patent Office.[6].

However as previously held in Dr Snehlata C Gupte v. Union of India, the date of the award of a patent for the submission of a post-grant opposition is the date on which the grant of a patent is published in the Patent Office Journal. The above two cases show the cloud covering the date on which a patent was issued with regard to the filing of patent opposition in India[7].

A significant corollary is that a short timeframe seems to exist where no opposition can be lodged (i.e. from the date of the grant order to the date of its publishing in the Patent Office Journal).

X. Judicial Precedents Interpretation

The prominent cases in India concerning patent opposition are as follows:

In the Chemtura case, the Delhi High Court stated that the obligation to change the status of the controller is not equal to simply specifying the countries of filing or the status of “pending or dismissed”. Furthermore, the duty is not met by telling the Controller once and for all regarding the filing of similar applications outside the country; rather the responsibility persists to notify the Controller from time to time of any changes in status[8].

The Supreme Court has elucidated in its ruling in the case of Dr Aloys Wobben & Anr. v. Yogesh Mehra & Ors. In accordance with Section 64 of the Patents Act, revocation may be sought either by a counterclaim in a suit for infringement OR by filing a petition for revocation before the IPAB; in both cases, the challenger may not attempt to proceed simultaneously against the patentee. Trying to follow one of the remedies would discourage him from using the other.

The Supreme Court, mindful that numerous suits were always a weapon for cash-rich litigants with rules designed for less than honest desires, viz.

Where an infringement suit has been lodged and a counter-claim for revocation has been made, it will be resolved upon revocation by the High Court. The claimant is barred from filing a dismissal appeal with the IPAB in the case for infringement (so long as it deals with the same matter).

Similarly, if a termination appeal against a patent is lodged with the IPAB and an infringement suit relating to the same patent is filed, the claimant in the case was disentitled from pursuing revocation of the patent at the time of filing his counter-claim. It will be determined on the revocation petition with the IPAB.[9]

• Novartis AG v. Natco Pharma Ltd [10]

Novartis AG, Switzerland filed a patent application in India on 17 July 1998, seeking the priority date of 18 July 1997 for Switzerland. Natco Pharma Ltd., an Indian firm, objected to the award of a patent on 26 May 2005 following the publication of the submission.

• The reasons for patent opposition were:
• Anticipation by previous publication;
• Lack of some sort of imaginative step;
• Patent non-patentability according to Section 3(d);
• A false statement of priority.

In a US Patent, which was filed in 1993, the title compound was previously known. The US patent asserted that the base compound salt was pharmaceutically permissible. Another paper called “Nature Medicine” (5 May 1996) also described the title compound; the salt stated to have existed naturally in the salt’s most stable state was also described. Accordingly, the arguments pertaining to the enforcement of the patent for the product and method with regard to the title compound were expected by previous publications.

Furthermore, on the grounds of section 3(d) of the Patent Act 1970, the invention argument merely refers to the invention of a new version of a material already known. Furthermore, the application for a patent asserted Swiss priority, but Switzerland was not a traditional country on the date of filing in Switzerland for the application for a patent. The priority of the Swiss application cannot however be asserted by the applicant corporation in relation to the Indian application.

In view of the aforementioned results and claims, the Patent Controller ruled that it was not necessary for Novartis AG, Switzerland, to issue a patent in India[11].

• Neon Laboratories Pvt. Ltd. v. Assistant Controller of Patent & Designs

In that decision, the Bombay High Court interpreted Section 25(1) of the Patent Act, 1970, to hold strongly that when an opponent of the Pre-Grant Opposition demands a hearing, it is necessary for the patent controller to grant a hearing as demanded by the opponent. In a written appeal lodged by Neon Laboratories, the order relating to the denial of hearing to the opponent was delivered.

The written appeal was lodged against the patent controller’s order to award a patent to Troika Pharma under Rule 55(6) of the Patent Rules, 2003, in the form of a pre-grant challenge to the patent[12].

• Hindustan Lever Ltd. v. Godrej Soaps [13]

A patent was filed in India on 14 Oct. 1992 by Hindustan Lever Ltd., which was objected by Godrej Soaps Ltd. The patent filed had two United Kingdom objectives, dated 14 October 1991 and 14 July 1992, and was granted in India on 18 May 1996.

The reasons for objecting to the patent were:

• Anticipation by previous publication;
• Prior awareness of the public and prior application of the public;
• Lack of inventive behaviour and lack of obviousness;
• In compliance with the Patent Act, 1970, non-patentability;
• Inadequacy of definition and clarity;

By virtue of section 8 of the Patent Act 1970, the applicant for the patent refused to reveal the details requested to the patent controller or supplied information which was incorrect in his/her knowledge relating to any particular content.

Following the hearing, the court found that the lessons of the exhibits cited were insufficient to prove the reasons for opposition alluded to in the opposition application. Subsequently, the claimant revised the requirements and statements in order to render the applicant’s argument transparent and to overcome the opponents’ charges.

The challenge to the patent was rejected by the court after considering the notice of opposition to the patent, the claims and the supporting facts of both parties and after hearing the case.

Subsequently, the claimant revised the requirements and statements in order to render the applicant’s argument transparent and to overcome the opponents’ charges. The challenge to the patent was rejected by the court after considering the notice of opposition to the patent, the claims and the supporting facts of both parties and after hearing the case.

XI. Conclusion

Opposition to patent litigation is more cost-effective and easier in contrast to other invalidation methods. Two forms of opposition are prescribed by the Patents Act, i.e. Pre-Grant and Post-Grant, which allow third parties flexibility to contest the validity of a patent even after the release of the patent within one year of its grant.

The role of the patent controller becomes increasingly important in the initial process of discarding the frivolous opposition of the patent and in avoiding the abuse of the patent opposition procedures. The controller is not required by any statute to enforce the opposition board’s recommendations.

Around the same time, the controller has a responsibility to take the recommendations of the opposition board into consideration. The Opposition Board’s suggestions are of great compelling importance because they are composed by experts. The controller is also under an implicit duty to include a formal statement, expressing his opinion as to whether he is not compliant with the opposition board’s recommendations.

If it is proven that for any good excuse, the Controller disregarded the report, the order passed will be vitiated for breaching the rules of natural justice and maybe set aside on appeal. The arrangement for the obligatory creation of an Opposition Board to provide expert advice during the post-grant opposition is based on clear judicial standards.

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References

[1] Bazzle, T. (2010). Pharmacy of the developing world: Reconciling intellectual property rights in India with the right to health: TRIPS, India’s patent system and essential medicines. Geo. J. Int’l L., 42, 785.

[2] Ganguli, P. (2004). Patents and patent information in 1979 and 2004: a perspective from India. World Patent Information.

[3] Section 25, The Patents Act of 1970.

[4] Cipla Ltd v Union of India, Civil Appeal 8479-8480, 2012.

[5] Shikha, Neeti, Comparative Study of Pre Grant and Post Grant Patent Opposition in India, (January 10, 2009), Available Here

[6] Sugen Inc v Cipla Ltd (CS (OS) 3429/2012),

[7] Dr Snehlata C Gupte v Union of India (WP (C) 3516, 3517, 5422, 5423 of 2007; 10399, 10400 and 10450 of 2009; and 1020 of 2010).

[8] Chemtura Corporation v. Union of India & Ors. In the High Court of Delhi, CS (OS) No. 930 of 2009.

[9] Enercon (India) Limited v. Aloys Wobben, (2013) 56 PTC 412 (IPAB).

[10] Novartis AG v. Natco Pharma Ltd 1602/MAS/1998.

[11] Lee, L. L. (2008). Trials and TRIPS-ulations: Indian patent law and Novartis AG v. Union of India. Berkeley Tech. LJ, 23, 281.

[12]Neon Laboratories Pvt. Ltd. vs. Assistant Controller of Patent & Designs, 2010 (112) BomLR 4901.

[13] Hindusthan Lever Limited vs Godrej Soaps Limited and Others on 11 April 1996, AIR 1996 Cal 367.

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